September 27, 2019. Singulair has serious side effects and we need much better data to determine the likely benefit and risk of harm for patients. FDA has an important role to play in encouraging this research. In the meantime, patients, parents, and clinicians must be given clear information about the risks so that they can make an informed decision about whether to use montelukast (Singulair).
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NCHR Comment on USPSTF’s Draft Recommendation Statement on Screening for Hepatitis C Infection
September 23, 2019. In general, we support the USPSTF draft recommendation related to HCV screening in adults; however, we are concerned about the potential for anxiety, stress, and other psychological harms for patients who are diagnosed with HCV but cannot afford to obtain treatment.
Read More »NCHR Testimony on Non-Prescription Nicotine Mouth Spray
September 18, 2019: This nicotine mouth spray has already been approved in several other countries, but that doesn’t mean that it is good product for the U.S. If we’ve learned anything from the Juul and vaping epidemic, it is that anything that delivers nicotine over the counter or online can be misused.
Read More »NCHR Testimony on Peanut Allergen Powder for Children with Peanut Allergy
September 13, 2019. This is the first treatment for peanut allergies and if this drug is approved despite the unanswered questions, it will set a precedent for future drugs to treat food allergies. It is especially important that new classes of products provide strong evidence of safety and efficacy before approval, because it will be difficult if not impossible to obtain it afterwards.
Read More »NCHR Comment on FDA’s Draft Guidance to Industry on Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy
September 10, 2019: In response to FDA’s request for public comments, we stated that the agency should require better testing of hormonal birth control pills and patches. Current studies don’t include enough women with higher BMIs or track blood clot risks properly. Our comments push for stronger safety standards that test hormonal contraceptives on women of all weights, especially since some birth control methods may be less effective or more dangerous for larger women.
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